10.13.15
Menlo Park, Calif.-based CardioKinetix Inc., a medical device company that makes catheter-based treatment for heart failure, has earned South Korean regulatory approval for the Parachute system, a ventricular partitioning device.
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.
“We are pleased to have received approval for the Parachute device, and are excited to introduce the therapy to patients with heart failure in South Korea,” said Maria Sainz, president and CEO of CardioKinetix. “The achievement of this milestone builds upon the technology adoption we are experiencing in the Asia market where we have treated the first 100 patients, completed a Chinese clinical trial, and recently received regulatory approval in Indonesia.”
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. The Parachute device offers a minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device, the CardioKinetix reports.
The Parachute ventricular partitioning device received CE Mark in 2011. In the United States, the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale. Currently CardioKinetix is enrolling an investigational device exemption study in the United States and Canada.
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.
“We are pleased to have received approval for the Parachute device, and are excited to introduce the therapy to patients with heart failure in South Korea,” said Maria Sainz, president and CEO of CardioKinetix. “The achievement of this milestone builds upon the technology adoption we are experiencing in the Asia market where we have treated the first 100 patients, completed a Chinese clinical trial, and recently received regulatory approval in Indonesia.”
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. The Parachute device offers a minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device, the CardioKinetix reports.
The Parachute ventricular partitioning device received CE Mark in 2011. In the United States, the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale. Currently CardioKinetix is enrolling an investigational device exemption study in the United States and Canada.